Clinical Trial Safety Monitoring.pptx

That slides would help students to know about clinical trials, safety of patient/healthy subjects and about data management.

1. Safety Monitoring in Clinical Trial Presented by, Dnyanshree V. Tijare M-Pharm (Pharmacology) Rajarshi Shahu College of Pharmacy malvihir , Buldana

2. Index What are clinical trials? What is Safety monitoring in clinical trials? Purpose of monitoring Stakeholder in safety monitoring Monitoring process 2/16

3. What are clinical trials? Clinical trials are set of tests/ systematic investigation in medical research and drug development that generate safety and efficacy data for health interventions in human beings. 3/16

4. What is safety monitoring in clinical trials The act of overseeing the progress of clinical trial and of ensuring that it is- conducted , recorded , and Reported in accordance with the protocol, SOPs , GCP and any regulatory requirements. 4/16

5. 5/16 Purpose of Monitoring

6. CBI A firm in Delhi- Synergy Network Dinesh Dua (Director) Bribe of Total 9 lakh on 28 th of june Bribe was for to waive phase lll for Bicon’s Aspart insulin Injection To skip no. lll trial High cost Time consuming Low success rate Catch them red handed While giving Bribe Gujjit Sethi, Director of ( Bioinnovate Research ) Bicon Biologics Limited CDSCO 6/16

7. Stakeholder in safety monitoring Sponsor Subjects Investigators IRB committee ( Institutional Review Board ) DSMB (Data and Safety Monitoring Board) Regulatory Authorities Medical Community and Patient 7/16

8. Sponsor Sponsor can be a person, group of people or a organization/ company Usually pharmaceutical companies are responsible for clinical trial Protocol Rationale of research, Objective of research, Exclusion/ Inclusion Criteria, Trial procedure, Sample size Informed consent form Case report form 8/16

9. Subject Patients or Healthy volunteers Who agree to participate in clinical trial, along with other information The informed consent must given freely ( Must be based on clear understanding ) By consent form, subjects permits investigators to collect health information 9/16

10. IRB Also known as ethics committee Is charged with protecting rights and welfare of human subjects (Recruit to clinical protocol) Has authority to Approve / Disapprove / Modify to protocol Training and education of Investigator in clinical research also responsibility of IRB committee 10/16

11. DSMB Also called Data Monitoring Committee Its mandate to review on regular basis the accumulating data from clinical trial to ensure safety of current participants Has additional responsibility to advice sponsor regarding continuing validity of clinical trials DSMBs are most common in double blind randomized phase 3 11/16

12. Regulatory Authorities FDA ( Food and DRUG Administration ) EMA ( European Medicinal Agency ) Example, US 12/16 Submission of IND application to FDA Initiation of Human clinical trial

13. Medical Community and Patients Clinical trials generate data that contribute to the body knowledge about the treatment and disease. Further expanded, , In 1997 , US congress pass the act FDAMA ( Food & Drug Modernization Act ) and clinical trial Gov. In 2007 , (Food & Drug Administration Amendments Act) FDAAA which require more types of trials to be registered In Sep 2008 , as per FDAAA 801 , Clinical Trial gov. began allowing sponsors and investigators to submit the result of clinical studies 13/16

14. Monitoring Process Review status of data entry Send agenda of Monitoring visit Assess/ Discuss- Site, Lab, Other facilities Discuss any problem/ Issue identified Complete site visit report Submit report to the sponsor 14/16

15. References Safety monitoring in clinical trials article by BinYao , Li zhu , Qi Jiang and H. amy Xia 15/16

16. Thank you…